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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN ISO 11737-2:2000 Th
2、e European Standard EN ISO 11737-2:2000 has the status of a British Standard ICS 07.100.10;11.080.01 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the validation of a sterilizati
3、on process This British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 May 2000 BSI 05-2000 ISBN 0 580 34033 3 BS EN ISO 11737-2:2000 Amendments issued since p
4、ublication Amd. No.DateComments National foreword This British Standard is the official English language version of EN ISO 11737-2:2000. It is identical with ISO 11737-2:1998. The UK participation in its preparation was entrusted to Technical Committee CH/67, Sterilization of medical devices, which
5、has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them i
6、n the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references Attention is drawn to the fact that CEN and CENELEC Standards normally include an annex which lists normative references to international publications with their correspondin
7、g European publications. The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled International Standards Correspondence Index, or by using the Find facility of the BSI Standards E
8、lectronic Catalogue. The Bibliography refers to ISO 11737-1, Sterilization of medical devices Microbiological methods Part 1: Estimation of the population of micro-organisms on products, the contents of which has been published in the United Kingdom as: BS EN 1174-1 Sterilization of medical devices
9、Estimation of the population of micro-organisms on product Part 1: Requirements; BS EN 1174-2 Sterilization of medical devices Estimation of the population of micro-organisms on product Part 2: Guidance; BS EN 1174-3 Sterilization of medical devices Estimation of the population of micro-organisms on
10、 product Part 3: Guide to the methods of validation of microbiological techniques. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itsel
11、f confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to iv, pages 1 to 13, the annex ZA page, an inside back cover and a back cover. The BSI copyright not
12、ice displayed in this document indicates when the document was last issued. EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11737-2 February 2000 ICS 07.100.10; 11.080 English version Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the va
13、lidation of a sterilization process (ISO 11737-2:1998) Strilisation des dispositifs mdicaux - Mthodes microbiologiques - Partie 2: Essais de strilit pratiqus en cours de validation dun procd de strilisation (ISO 11737-2:1998) Sterilisation von Medizinprodukten - Mikrobiologische Verfahren - Teil 2:
14、Sterilittsprfungen bei der Validierung eines Sterilisationsverfahrens (ISO 11737-2:1998) This European Standard was approved by CEN on 17 December 1999. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the stat
15、us of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member. This European Standard exists in three official versions (English, French, German). A v
16、ersion in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, F
17、rance, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Central Secretariat: rue de Stassart, 36 B-1050 Brussels 200
18、0 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11737-2:2000 E Foreword The text of the International Standard from Technical Committee ISO/TC 198 “Sterilization of health care products“ of the International Organization for S
19、tandardization (ISO) has been taken over as an European Standard by Technical Committee CEN/TC 204 “Sterilization of medical devices“, the secretariat of which is held by BSI. This European Standard shall be given the status of a national standard, either by publication of an identical text or by en
20、dorsement, at the latest by August 2000, and conflicting national standards shall be withdrawn at the latest by August 2000. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belg
21、ium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of the International Standard ISO 11737-2:21998 has been approved by CEN as a European St
22、andard without any modification. NOTE: Normative references to International Standards are listed in annex ZA (normative). EN ISO 11737-2:2000 AReference number ISO 11737-2:1998(E) INTERNATIONAL STANDARD ISO 11737-2 First edition 1998-07-01 Sterilization of medical devices Microbiological methods Pa
23、rt 2: Tests of sterility performed in the validation of a sterilization process Strilisation des dispositifs mdicaux Mthodes microbiologiques Partie 2: Essais de strilit pratiqus en cours de validation dun procd de strilisation EN ISO 11737-2:2000 ii Contents Page 1 Scope 1 2 Normative references 1
24、3 Terms and definitions . 1 4 General 2 5 Selection and preparation of product units for testing . 3 6 Tests of sterility . 4 7 Assessment of method for test of sterility 4 Annex A (informative) Guidance on tests of sterility performed in validation of a sterilization process 5 Bibliography 12 EN IS
25、O 11737-2:2000 iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a su
26、bject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non- governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission
27、(IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an Inte
28、rnational Standard requires approval by at least 75 % of the member bodies casting a vote. International Standard ISO 11737-2 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. ISO 11737 consists of the following parts, under the general title Sterilization of med
29、ical devices Microbiological methods: Part 1: Estimation of the population of microorganisms on product Part 2: Tests of sterility performed in the validation of a sterilization process Annex A of this International Standard is for information only. EN ISO 11737-2:2000 iv Introduction A sterile prod
30、uct item is one which is free of viable microorganisms. The International Standards for sterilization of medical devices require, when it is necessary to supply a sterile product item, that adventitious microbiological contamination of a medical device from all sources be minimized by all practical
31、means. Even so, product items produced under standard manufacturing conditions in accordance with the requirements for quality systems for medical devices may, prior to sterilization, have microorganisms on them, albeit in low numbers. Such product items are non-sterile. The purpose of sterilization
32、 processing is to inactivate the microbiological contaminants and thereby transform the non-sterile items into sterile ones. The inactivation of a pure culture of microorganisms by physical and/or chemical agents used to sterilize medical devices often approximates an exponential relationship; inevi
33、tably this means that there is always a finite probability that a microorganism may survive regardless of the extent of treatment applied. For a given treatment, the probability of survival is determined by the number and resistance of microorganisms and by the environment in which the organisms exi
34、st during treatment. It follows that the sterility of any one item in a population of items subjected to sterilization processing cannot be guaranteed, and the sterility of the processed population of items has to be defined in terms of the probability of the existence of a non-sterile item in that
35、population. Requirements for the quality system for the design/development, production, installation and servicing of medical devices are given in ISO 9001 and ISO 9002 in conjunction with ISO 13485 and ISO 13488, respectively. The ISO 9000 series of standards designates certain processes used in ma
36、nufacture as special if the results cannot be fully verified by subsequent inspection and testing of the product. Sterilization is an example of a special process because process efficacy cannot be verified by inspection and testing of the product. For this reason, sterilization processes have to be
37、 validated before use, the performance of the process monitored routinely and the equipment maintained. International Standards specifying procedures for the validation and routine control of the processes used for sterilization of medical devices have been prepared (see ISO 11134, 11135 and 11137).
38、 An element of this validation may consist of exposing medical devices to the sterilizing agent when the extent of treatment has been reduced relative to that which will be used in routine processing in order to provide a knowledge of the resistance to the agent of the microbial contamination as it
39、occurs naturally on medical devices. Subsequent to this exposure, medical devices are subjected individually to tests of sterility as described in this part of ISO 11737. An example of the use of such a test is in establishing a sterilizing dose for sterilization by radiation and for demonstrating t
40、he continued validity of this sterilization dose (see ISO 11137, Annex B). Annex A of this part of ISO 11737 gives guidance on the techniques used and on practical aspects of the requirements. EN ISO 11737-2:2000 1 Sterilization of medical devices Microbiological methods Part 2: Tests of sterility p
41、erformed in the validation of a sterilization process 1 Scope 1.1 This part of ISO 11737 specifies the general criteria for tests of sterility on medical devices which have been exposed to a treatment with the sterilizing agent that is a fraction of the specified sterilization process. These tests a
42、re intended to be performed when validating a sterilization process. 1.2 This part of ISO 11737 is not applicable to: a) sterility testing for routine release of product that has been subjected to a sterilization process; b) performance of a pharmacopoeial test for sterility; or NOTE 1 The performan
43、ce of a) or b) above is not a requirement of ISO 11134, 11135 or 11137. c) culturing of biological indicators, including inoculated products. NOTE 2 Methods of culturing biological indicators are described in ISO 11138. 2 Normative references The following normative documents contain provisions whic
44、h, through reference in this text, constitute provisions of this part of ISO 11737. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this part of ISO 11737 are encouraged to investigate the possibility of
45、 applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 9001:1994, Quality Systems Model for qual
46、ity assurance in design, development, production, installation and servicing. ISO 9002:1994, Quality systems Model for quality assurance in production, installation and servicing. 3 Terms and definitions For the purposes of this part of ISO 11737, the following terms and definitions apply. 3.1 aerob
47、ic organism microorganisms that utilize oxygen as the final electron acceptor during metabolism and which will only grow in the presence of oxygen EN ISO 11737-2:2000 2 3.2 anaerobic organism microorganisms that do not utilize oxygen as the final electron acceptor during metabolism and which will on
48、ly grow in the absence of oxygen 3.3 bacteriostasis/fungistasis test test performed with selected microorganisms to demonstrate the presence of substances that inhibit the multiplication of these microorganisms 3.4 culture conditions stated combination of conditions, including the growth medium with
49、 the period and temperature of incubation, used to promote growth and multiplication of microorganisms 3.5 facultative organism microorganism capable of both aerobic and anaerobic metabolism 3.6 false negative result of a test of sterility in which a true positive is interpreted as negative 3.7 false positive result of a test of sterility in which a true negative is interpreted as a positive 3.8 growth promotion test test performed to demonstrate that a given medium will support microbial growth 3.9 prod
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